A phase 1/1b/2 study evaluating the safety tolerability pharmacokinetics pharmacodynamics and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors

Brief description of study

This study is for adults who have advanced solid tumors that lack a certain enzyme called methylthioadenosine phosphorylase (MTAP). This study is split into two parts. The main goal of Parts 1 and 2 of this study is to see if AMG 193 (Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor) is safe to use alone or with docetaxel, and to find the highest dose that can be used without causing serious side effects. AMG 193 is a drug that can be taken by mouth and may help stop the growth of cancer cells.

The main goal of Part 3 of this study is to see how well AMG 193 works in adults who have advanced non-small cell lung cancer that lacks the MTAP enzyme. This part of the study is for people who have already received chemotherapy and/or a PD-1/L1 inhibitor treatment. The researchers will look at how many people's tumors shrink or disappear after taking AMG 193.


Clinical Study Identifier: s22-00727
Principal Investigator: Nina Beri.
Other Investigators: Nila Theresa De La Rosa, Amber M Lewis, Scot Niglio, Jeffrey S. Weber, Salman Rafi Punekar, Samantha VanMaanen, Elaine Shum, Jessica Wang, Kristen Spencer, Joshua K Sabari, Keriann M Scavone, Cosmin Adrian Tegla, Kathleen M Madden, Caitlin Elizabeth Ryan, Douglas K Marks, Janice Mehnert, David R. Wise.


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